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Clinical Observation and Mechanism Study of Xu's Shenqi Yizhu Decoction Combined with Chemotherapy in the Treatment of Cancer-related Fatigue of Stagnated-toxin Spleen Deficiency Type in Postoperative Gastric Cancer Patients
Enhanced Publication- Chinese Journal of Experimental Traditional Medical Formulae Vol. 31, Issue 8, Pages: 143-151(2025)
- Affiliations：
Affiliated Hospital of Nanjing University of Chinese Medicine，Nanjing 210029，China
- Author bio：
- Funds：
DOI：10.13422/j.cnki.syfjx.20251091
CLC： R259;R587.1;R544.1Received：10 December 2024，
Accepted：17 February 2025，
Published Online：27 February 2025，
Published：20 April 2025
- Accepted：
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沈志祥,陆为民,石川等.徐氏参芪苡术汤联合化疗治疗胃癌术后癌因性疲乏脾虚瘀毒型的临床观察及机制[J].中国实验方剂学杂志,2025,31(08):143-151.
SHEN Zhixiang,LU Weimin,SHI Chuan,et al.Clinical Observation and Mechanism Study of Xu's Shenqi Yizhu Decoction Combined with Chemotherapy in the Treatment of Cancer-related Fatigue of Stagnated-toxin Spleen Deficiency Type in Postoperative Gastric Cancer Patients[J].Chinese Journal of Experimental Traditional Medical Formulae,2025,31(08):143-151.
沈志祥,陆为民,石川等.徐氏参芪苡术汤联合化疗治疗胃癌术后癌因性疲乏脾虚瘀毒型的临床观察及机制[J].中国实验方剂学杂志,2025,31(08):143-151. DOI： 10.13422/j.cnki.syfjx.20251091.
SHEN Zhixiang,LU Weimin,SHI Chuan,et al.Clinical Observation and Mechanism Study of Xu's Shenqi Yizhu Decoction Combined with Chemotherapy in the Treatment of Cancer-related Fatigue of Stagnated-toxin Spleen Deficiency Type in Postoperative Gastric Cancer Patients[J].Chinese Journal of Experimental Traditional Medical Formulae,2025,31(08):143-151. DOI： 10.13422/j.cnki.syfjx.20251091.
摘要
目的
2
评价徐氏参芪苡术汤治疗胃癌术后化疗癌因性疲乏（CRF）脾虚瘀毒型的临床疗效，并探讨其可能机制。
方法
2
选取50例胃癌术后CRF脾虚瘀毒型患者，采用随机数字表法分为观察组、对照组，每组各25例。对照组予FLOT方案化疗（多西紫杉醇50 mg·m
-2
第1天静脉滴注+奥沙利铂85 mg·m
-2
第1天静脉滴注+亚叶酸钙200 mg·m
-2
第1天静脉滴注+氟尿嘧啶2 600 mg·m
-2
第1天24 h持续静脉滴注，3周/次）及基础、对症支持治疗，观察组在对照组的基础上同时予徐氏参芪苡术汤治疗（水煎2次，200 mL口服，2次/d）。3周为1个疗程，共4疗程。观察两组治疗前后Piper疲乏量表（PFS）评分、Karnofsky Performance Status（KPS）量表评分、欧洲癌症治疗研究组织生命质量核心（EORTC-QLQ-C30）量表评分、中医证候评分，酶联免疫吸附测定法（ELISA）检测血清肿瘤坏死因子-
α
（TNF-
α
）、
γ
干扰素（IFN-
γ
）、白细胞介素-6（IL-6）水平，记录两组患者治疗前后安全性检查结果及治疗期间不良事件发生情况。从基因表达综合数据库（GEO）下载胃腺癌患者及正常人外周血样本的转录组测序数据，并鉴定肿瘤组和正常组间的差异表
达基因，根据京都基因与基因组百科全书（KEGG）和基因本体（GO）进行差异基因富集分析。从基因卡片（GeneCards）数据库获取基因的CRF相关性评分。
结果
2
①与本组治疗前比较，观察组PFS总疲乏评分明显降低（
P
<
0.05）；与对照组治疗后比较，观察组PFS总疲乏评分明显降低（
P
<
0.05）；②与本组治疗前比较，观察组KPS评分明显降低（
P
<
0.05）；与对照组治疗后比较，观察组KPS评分明显降低（
P
<
0.05）；与本组治疗前比较，观察组EORTC-QLQ-C30量表功能领域（躯体功能、角色功能、情绪功能、社会功能）及总体健康领域评分明显增高，症状领域评分（疲乏、气促、食欲不振、便秘、腹泻）明显降低（
P
<
0.05）；与对照组治疗后比较，观察组EORTC-QLQ-C30量表功能领域（躯体功能、情绪功能、社会功能）及总体健康领域评分明显增高（
P
<
0.05），症状领域评分疲乏、恶心呕吐、气促、食欲不振、腹泻明显降低（
P
<
0.05）；与本组治疗前比较，观察组中医证候评分（食少纳呆、体倦乏力、食后腹胀、大便异常、神疲乏力、总分）明显降低（
P
<
0.05）；与对照组治疗后比较，观察组中医证候评分（食少纳呆、体倦乏力、恶心呕吐、面色萎黄）明显降低（
P
<
0.05），观察组疗效优于对照组（
χ
2
=7.996，
P
<
0.05）；血清TNF-
α
、IL-6、IFN-
γ
水平之间呈两两相关（
P
<
0.01）。与本组治疗前比较，观察组血清细胞因子TNF-
α
、IL-6、IFN-
γ
水平明显降低（
P
<
0.05）；与对照组治疗后比较，观察组血清细胞因子TNF-
α
、IL-6、IFN-
γ
水平明显降低（
P
<
0.05）；③两组患者治疗前后安全性检查结果的组内和组间比较差异均无统计学意义；治疗期间，两组患者不良反应发生率差异无统计学意义。④与正常组外周血比较，肿瘤组患者外周血中共有328个基因表达明显上调（
P
<
0.05），KEGG和GO分析显示其明显富集于TNF等信号通路（
P
<
0.05）。⑤TNF、IL6、IFNG等细胞因子编码基因可能是CRF关键致病基因。
结论
2
徐氏参芪苡术汤可缓解胃癌术后化疗患者CRF的疲乏等症状，提高患者功能状况、生命质量，其机制可能与改善细胞因子失调有关。
Abstract
Objective
2
To evaluate the clinical efficacy of Xu's Shenqiyizhu （SQYZ） decoction combined with chemotherapy in the treatment of cancer-related fatigue （CRF） of stagnated-toxin spleen deficiency type after gastric cancer surgery and explore its possible mechanism.
Methods
2
Fifty postoperative gastric cancer patients with CRF of stagnated-toxin spleen deficiency type were selected and randomly divided into an experimental group and a control group by using a random number table，with 25 cases
in each group. The control group was treated with FLOT chemotherapy （50 mg·m
-2
docetaxel （
iv
drip on day 1） + 85 mg·m
-2
oxaliplatin （
iv
drip on day 1） + 200 mg·m
-2
calcium folinate （
iv
drip on day 1） + 2 600 mg·m
-2
fluorouracil （
iv
drip for 24 h on day 1），once every three weeks） and basic and symptomatic supportive treatment. The experimental group was treated with Xu's SQYZ decoction （decocted twice，200 mL taken orally twice a day） in addition to the treatment of the control group. One course of treatment lasted for three weeks，with a total of four courses conducted. Observation was performed on the piper fatigue scale （PFS） scores，karnofsky performance status （KPS） scores，European Organization for Research and Treatment of cancer quality of life questionnaire （EORTC QLQ-C30） scores，traditional Chinese medicine syndrome scores，and serum levels of tumor necrosis factor-
α
（TNF-
α
），interferon-
γ
（IFN-
γ
），and interleukin-6 （IL-6）detected via enzyme linked immunosorbent assay （ELISA） before and after treatment in the two groups. The safety test results before and after treatment for the two groups of patients，as well as the occurrence of adverse events during treatment， were recorded. Transcriptome sequencing data of peripheral blood samples from gastric adenocarcinoma patients and normal individuals were downloaded from the gene expression omnibus （GEO） database，and differentially expressed genes between the tumor and normal groups were identified. Differential gene enrichment analysis was made based on the Kyoto Encyclopedia of Genes and Genomes （KEGG） and Gene Ontology （GO）. The CRF relevance scores of genes were retrieved from the GeneCards database.
Results
2
① Compared with that before treatment，the total PFS score in the experimental group was significantly reduced （
P
<
0.05）. Compared with
the control group after treatment，the experimental group showed significantly reduced total PFS score （
P
<
0.05）. ② Compared with that before treatment，the KPS score in the experimental group decreased significantly （
P
<
0.05）. Compared with the control group after treatment，the experimental group exhibited a significantly decreased KPS score （
P
<
0.05）. The experimental group demonstrated significantly increased functional scores （physical function，role function，emotional function，social function，and overall health） （
P
<
0.05） and significantly reduced symptom scores （fatigue，shortness of breath，loss of appetite，constipation，and diarrhea） of the EORTC QLQ-C30 scale after treatment compared with before treatment. Compared with the control group after treatment，the experimental group presented significantly increased functional scores （physical function，emotional function，social function，and overall health） （
P
<
0.05） and significantly reduced symptom scores （fatigue，nausea and vomiting，shortness of breath，loss of appetite，and diarrhea） of the EORTC QLQ-C30 scale （
P
<
0.05）. Compared with those before treatment，the traditional Chinese medicine syndrome scores （eating too little and poor digestion，fatigue and weakness，postprandial bloating，abnormal bowel movements，lassitude and weakness，and total score） in the experimental group were significantly reduced （
P
<
0.05）. Compared with the control group after treatment，the experimental group had significantly reduced traditional Chinese medicine syndrome scores （eating too little and poor digestion，fatigue and weakness，nausea and vomiting，and sallow complexion） （
P
<
0.05）， which indicated better efficacy in the experimental group than in the control group （
χ
2
=7.996，
P
<
0.05）. The serum levels of TNF-
α
，IL-6，and IFN-
γ
were significantly correlated wit
h each other （
P
<
0.01）. Compared with those before treatment，the levels of serum cytokines TNF-
α
，IL-6，and IFN-
γ
in the experimental group were significantly reduced （
P
<
0.05）. Compared with the control group after treatment，the experimental group showed significantly reduced serum levels of cytokines TNF-
α
，IL-6，and IFN-
γ
（
P
<
0.05）. ③ There were no significant intra-group and inter-group differences in the safety test results of the two groups before and after treatment. During the treatment period，there was no significant difference in the incidence of adverse reactions between the two groups of patients. ④ Compared with the normal group，the tumor group exhibited a total of 328 significantly up-regulated genes in the peripheral blood （
P
<
0.05），and KEGG and GO analyses showed that they were significantly enriched in signaling pathways such as TNF （
P
<
0.05）. ⑤ TNF，IL6，IFNG， and other cytokine encoding genes may be key pathogenic genes for CRF.
Conclusion
2
Xu's SQYZ decoction can alleviate symptoms such as fatigue in postoperative chemotherapy patients with gastric cancer and improve their functional status and quality of life. Its mechanism may be related to improving cytokine imbalance.
关键词
Keywords
references
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